Senior Plant Engineer
* Responsible for the overall performance and monitoring of plant utility systems. Responsible for providing operational support and will be a technical solution provider for plant utility systems that include clean utility (PW, WFI, CS, Process Gas, HVAC, Environmental Chambers, etc.) and base utility systems (Chilled/Hot Water, Plant Steam, Waste Treatment, etc.). The operational support will include equipment/system troubleshooting and providing in-house engineering expertise to the facilities staff. Will be the subject matter expert and technical owner for clean utility, plant utility, and general facility systems.
* Responsible for providing technical engineering guidance for capital projects.
* This position requires experience and technical expertise with both clean and base utility systems. Electrical engineering and/or structural engineering experience a plus. Responsibilities include trouble-shooting, determining root cause of probl
ems and providing optimization strategies for utility systems within a multi-product, FDA regulated GMP facility.
* Candidate will be responsible for directing external engineering contractors and vendors for utility systems. All system improvements will be made in conjunction with manufacturing, facilities, manufacturing technical services, validation, quality assurance and regulatory.
* Must be able to work in a fast paced multi-disciplinary environment.
* Troubleshooting support for complex utility equipment problems as elevated by Eng I /II
* Serves as subject matter expert to support assigned work orders and close out Quality Systems as applicable
* Serves as subject matter expert for Regulatory filings as applicable
* On call support 24/7
* Covers all Shire Rare Disease sites including Lexington Campus, Alewife, Belmont and North Reading.
Small Project Support (cross-site in scope)
* Accountable for all phases of the Change Control process for owned changes
* Owns and ensures timely closure of equipment related CAPAs
* Provide and/or ensure generation of all supporting documentation (scope documents; approval slides; work orders; protocols)
* Use project management skills to schedule, track progress, and make adjustments
* Defines all aspects of project scope
* Uses appropriate business / quality systems such as Trackwise, Datastream, QHR's, etc.
* Knowledge of how small projects to tie in to other sites. * Provide peer review for all QA and Engineering documentation
Standards and Templates
* Develop engineering standard practices that will result in consistent, reproducible documents site-to-site
* Creates templates to be used at all sites for URS/FS/DDS
* Identifies equipment specific best practices and performs gap analysis between Shire and best practice
* Keep abr east of advancement in new technologies
* Develop / Improve Commissioning Guidelines and Templates
* Provide utility system inputs in support of the plant capacity model
Large Project Support
* Lead in development of user requirements for utility systems.
* Provide project team with utility system engineering design requirements
* Provide technical support as required. Education and Experience Requirements:
* Required education: Bachelors degree in Mechanical or Chemical Engineering
* Minimum 5-8 years experience with plant utility systems
* Minimum 5+ years experience in equipment design and oversight of fabrication
PE license is a plus Key Skills, Abilities, and Competencies:
* Effective verbal and written communication skills
* Excellent interpersonal and teamwork skills required
* Adherence to domestic and international GMP regulations
* Ability to multi-task in a dynamic environment wit h changing priorities
* Proficiency with Microsoft products; ability to learn additional software applications, as the need arises
* TrackWise experience a plus.
Other Job Requirements:
* Ability to work at all Shire MA locations.
* Driver's license is required for travel between sites.
* Required to carry a blackberry or iphone device and be on call to provide operational support.
* Must be able to climb a ladder, reach, bend and lift loads up to 50 lbs. Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives
As an Equal Opportunity and Affirmative Action Employer, Shire is committed to a diverse workforce. US Applicants who require accommodation in the job application process may contact 484-595-8400.
To apply for this position, please CLICK HERE